Recofluid
Italy
Table of Contents
Package leaflet: Information for the patient
Recofluid 750 mg/15 ml syrup
carbocysteine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 14 days.
Contents of this leaflet:
- What Recofluid is and what it is used for
- What you need to know before taking Recofluid
- How to take Recofluid
- Possible side effects
- How to store Recofluid
- Contents of the pack and other information
1. What Recofluid is and what it is used for
Recofluid is a syrup containing the active substance carbocisteine, which belongs to a group of medicines called mucolytics. These act by liquefying mucus in the respiratory tract and facilitating its elimination.
Recofluid is used to treat acute respiratory diseases characterized by the presence of thick and viscous sputum.
Consult your doctor if you do not feel better or if you feel worse after a maximum treatment period of 14 days.
2. What you need to know before taking Recofluid
Do not take Recofluid
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if you have a lesion in the inner wall of the stomach or intestine (gastroduodenal ulcer);
- if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
You should consult your doctor also if such conditions have occurred in the past.
Warnings and precautions
Talk to your doctor or pharmacist before taking Recofluid.
The increase in mucus secretion that you may notice from the first days of treatment will rapidly subside.
If symptoms of hypersensitivity occur, discontinue treatment.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory disorders, debilitated patients, those with a history of gastroduodenal ulcers, or those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine if gastrointestinal bleeding occurs.
This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.
Children and adolescents
Recofluid is indicated only for adults.
Other medicines and Recofluid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Recofluid must not be used during pregnancy and breastfeeding.
Its use should also be avoided if you suspect you are pregnant or are planning to become pregnant.
Driving and using machines
Recofluid does not affect, or has a negligible effect on, the ability to drive vehicles or operate machinery.
Recofluid contains sorbitol
This medicine contains 3 g of sorbitol per 15 ml of syrup (1 tablespoon).
Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before taking this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.
Recofluid contains methyl parahydroxybenzoate
Methyl parahydroxybenzoate contained in Recofluid may cause allergic reactions (including delayed-type reactions).
3. How to take Recofluid
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take this medicine only for short periods. If symptoms have not improved after 14 days of treatment, you are advised to consult a doctor.
Recofluid is intended for use in adults only.
The recommended dose is 2–3 tablespoons per day, with an interval of 8 hours between doses (1 tablespoon corresponds to 15 ml = 750 mg).
Warning: Do not exceed the recommended dose without consulting your doctor.
You may take Recofluid independently of meals.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Warning: Use Recofluid only for short-term treatment.
For oral use.
Instructions for opening the bottle:
- To open, press and 2) To close, press and
unscrew simultaneously screw simultaneously
Use in children and adolescents
Recofluid is not indicated for use in children and adolescents.
If you take more Recofluid than you should
Symptoms of overdose may include: headache, nausea, diarrhea, stomach pain.
In case of accidental ingestion or overdose of Recofluid, contact your doctor immediately or go to the nearest hospital.
If you forget to take Recofluid
Do not take a double dose to make up for the missed dose.
If you stop treatment with Recofluid
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):
- dizziness
- digestive disorders (stomach pain, nausea, diarrhoea, gastrointestinal bleeding)
- allergic skin rashes
- Stevens-Johnson syndrome
- bullous dermatitis
- severe sudden allergic reactions (anaphylactic reactions)
- skin irritation with skin redness (fixed erythema)
- erythema multiforme
- toxic skin eruption
- reduction, generally reversible, in the number of certain blood cells (leucopenia, agranulocytosis, thrombocytopenia, anaemia); this may exceptionally occur in sensitive individuals and in patients treated with certain antidiabetic medicines (sulphonamides).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Recofluid
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after the word
“Expiry”.
The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 10 days; any remaining quantity must be
discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Recofluid contains
- The active substance is carbocisteine. 100 ml of syrup contain 5 g of carbocisteine.
- The other ingredients are raspberry flavour, methyl p-hydroxybenzoate, 70% sorbitol, purified water.
Description of the appearance of Recofluid and contents of the pack
Recofluid is a raspberry-flavoured oral syrup. The pack contains one 150 ml bottle.
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milan.
Manufacturer
Francia Farmaceutici s.r.l. - Via Pestagalli, 7 – Milan.